Biopharma Update on the Novel Coronavirus: July 20
News information is not all-inclusive and updates will now be published on Mondays, Wednesdays and Fridays.
EUAs: The FDA issued EUAS to:
- Boston Heart Diagnostics (Boston Heart COVID-19 RT-PCR Test)
- Luminex Corporation (xMAP SARS-CoV-2 Multi-Antigen IgG Assay)
Abbreviated New Drug Application: The FDA approved an abbreviated new drug application for a generic anti-coagulant, heparin sodium.
Diagnostics Update: To-date the FDA has authorized 184 individual EUAs, which include 152 molecular tests, 30 antibody tests and 2 antigen tests.
Sample Pooled Testing: The FDA reissued a EUA to Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR test. The test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.
Fluidigm announced that Gnome Diagnostics is utilizing its microfluidics technology and reagents in a test developed to detect the SARS-CoV-2 virus.
Testing Therapies, Antivirals and Vaccines
AstraZeneca’s COVID-19 vaccine candidate induced significant immune responses in the majority of patients following a single dose in a Phase I study. The preventative medication also proved to be fairly safe, study results showed. AstraZeneca and its development partner, the Jenner Institute from Oxford University, published the results of the Phase I study in The Lancet this morning.
A small biotech company in Southampton, UK, Synairgen, announced positive results from a clinical trial of its wholly-owned inhaled formulation of interferon-beta in COVID-19 patients. Company shares exploded 373% at the news.
Another COVID-19 vaccine candidate recently entered the races. The difference – this one is a live attenuated (weakened) virus expressing the coronavirus’s signature spike protein on its surface. And it’s delivered nasally, not a shot.“COVID-19 vaccine development will be more of a marathon than a sprint,” Martin Moore, Ph.D., co-founder and CEO of Meissa Vaccines, told BioSpace. “A live attenuated vaccine may not be first-in-class, but their historically high efficacy could make it the best-in-class.”
Innovation Pharmaceuticals announced new data results from laboratory testing of Brilacidin for COVID-19. The results show that Brilacidin inhibits COVID-19 by almost 90% at the lowest concentration in a human lung cell line.
Pfizer and BioNTech reported additional data from their COVID-19 vaccine. The data is shown it is safe and produces an immune response in patients.
New York-based Pfizer and Mainz, Germany-based BioNTech, which are developing BNT162, an mRNA-based vaccine against COVID-19, signed a deal with the United Kingdom to manufacture 30 million doses.
Other Industry News
As reported by Reuters, researchers in London have identified six types of COVID-19, each distinguished by a cluster of symptoms. The findings are believed to help doctors predict patients who are at most risk.